1. BIOPROSPECTING, ACCESS & BENEFIT SHARING IN SOUTH AFRICA Carina Malherbe 5 th Pan African ABS Workshop, Marrakech 3 February 2011 1

2. AIM OF THE PRESENTATION To give overview on the regulation of bioprospecting, access and benefit sharing in South Africa To share South African experiences in the implementation of ABS legislation 2

3. SOUTH AFRICAN DIVERSITY SA is the 3 rd most biologically diverse country in the world, after Indonesia and Brazil Our seas straddle 3 oceans: the Atlantic, Indian and Southern Ocean SA occupies about 2% of the world's land area, but is home to nearly –10% of the world's plants –7% of the reptiles, birds and mammals & –15% of known coastal marine species 3

4. 4 Constitution Section 24 National Environmental Management Act 107 of 1998 National Environmental Management Biodiversity Act 10 of 2004 Biodiversity Planning & Monitoring Threatened or Protected Ecosystems & Species Threats to Biodiversity Bioprospecting, Access & Benefit Sharing BABS Regulations

5. NATIONAL ENVIRONMENTAL MANAGEMENT BIODIVERSITY ACT, Act 10 of 2004 (NEMBA) 5 Objectives Management & conservation of biodiversity Ensure sustainable use of IBR Ensure fair and equitable sharing of benefits with indigenous communities arising from bioprospecting involving –indigenous biological resources (IBR) &/or –associated traditional knowledge (TK) in South Africa

6. BIOPROSPECTING, ACCESS & BENEFIT SHARING REGULATIONS The purpose of these regulations is to – Regulate the bioprospecting permit system Set out the contents, requirements and criteria for benefit- sharing and material transfer agreements The regulations govern – The discovery and/or commercialisation phase of a bioprospecting project The export of any IBR from South Africa for purposes of bioprospecting, or any other kind of research The BABS Regulations came into force on 1 April 2008 6

7. LEGISLATIVE OVERVIEW Regulation of utilization of IBR & associated TK Protection of rights of stakeholders Framework for Agreements Bioprospecting Trust Fund Exemptions – activities or species Offences Penalties 7

8. NEMBA ENABLING PROVISIONS NEMBA Chapter 6: Sections 81(1) and 81A 81(1) A person may not without a permit engage in commercialisation phase of bioprospecting involving IBR, or export IBR for bioprospecting or any other kind of research 81A No person may without first notifying the Minister engage in discovery phase bioprospecting involving any IBR; and a person involved in the discovery phase of bioprospecting must sign a commitment to comply with the requirements at the commercialisation phase of bioprospecting 8

9. REGULATORY SYSTEM 9 Research Export permit for research other than bioprospecting Export agreement for ex situ material Discovery phase Notification of the Minister Commercialisation phase Bioprospecting permit Integrated export & bioprospecting permit

10. WHAT IS BIOPROSPECTING? Research on, development or application of indigenous biological resources (IBR) for commercial or industrial exploitation Search, collection, gathering of resources or making extractions for research, development or application Utilisation of traditional uses of IBR for research or development Research on, application, development or modification of traditional uses for commercial or industrial exploitation 10

11. INDIGENOUS BIOLOGICAL RESOURCES Animals, plants or other organisms of indigenous species Includes Living or dead Genetic material Gathered from the wild Cultivated, bred or kept in captivity Exotic animals, plants or other organisms altered with genetic materials or bio-compounds from indigenous species Excludes Genetic material of human origin All other exotic animals, plants or other organisms 11

12. COMMERCIALISATION -Filing of intellectual property (IP) / patent application in SA or elsewhere -Obtaining or transfer of IP rights -Commencement of clinical trials & product development, including market research -Multiplication of IBRs through cultivation, propagation, or cloning to develop and produce: medicines, enzymes, food flavours, fragrances, cosmetics, essential oils, colours and extracts 12

13. Traditional Knowledge Holder Indigenous community or individual whose traditional uses, knowledge or discoveries of the indigenous biological resource are used as basis for bioprospecting STAKEHOLDER PROTECTION The legislation protects the interest of certain stakeholders: Access Provider Person / community / organ of state who provides access to indigenous biological resources 13

14. The permit applicant must – Disclose all material information relevant to the proposed bioprospecting to the stakeholder Obtain prior consent of the stakeholder for access to IBR and / or use of the traditional knowledge > Enter into material transfer agreements (MTA) that regulate access to IBR > Enter into benefit-sharing agreements (BSA) that provide for the sharing in any future benefits that may be derived from the proposed bioprospecting > BSA & MTA subject to approval by Minister STAKEHOLDER PROTECTION 14

15. PENALTIES A person convicted of any offence in terms of engaging in commercialization of bioprospecting or the export of IBR without a permit is liable to – Imprisonment not exceeding 5 years –10 years for second offences Fine not exceeding R5-million –R10-million for second offences Both fine and imprisonment 15

16. The Minister may only approve a BSA if satisfied that – The BSA is fair and equitable to all parties -Consult any person competent to provide technical advice on the agreement  bioprospecting expert group -Invite public comment The Minister may refuse to approve a BSA unless it provides for – -Enhancement of scientific knowledge and technical capacity of persons, organs of state or indigenous communities to conserve, use and develop IBR -Any other activity that promotes the conservation, sustainable use and development of the relevant IBR APPROVAL OF BSAs 16

17. IMPLEMENTATION STATUS 58 bioprospecting projects –Notifications –Benefit sharing / Material transfer agreements  Permit applications 2 permits issued Stakeholder awareness campaigns Compliance EMI & hotline + 27 800 205 005 Capacity building National Enforcement Unit – Interpol, Customs, CITES, SA Police, National Prosecuting Authority 17

18. Identification and protection of stakeholders –Access providers  supply chain –Knowledge holders: Indigenous communities & individuals Verification of knowledge owners –Traditional council / traditional healer / community representative –Prior informed consent & Mutually agreed terms: MTA & BSA Definitions 18 KEY CHALLENGES

19. KEY CHALLENGES (2) Negotiations on equal footing – assistance to communities Collection, use, propagation, cultivation or trade of IBR for domestic or subsistence purposes Muthi markets 19

20. Sceletium tortuosum: small genus, low growing succulent shrub, endemic to Western, Eastern & Northern Cape Used by Khoi & San 1662 Research initiated at Paulshoek & Nourivier communities: Nama people Origin of traditional knowledge Prior Informed Consent and Mutually Agreed Terms for utilization and Benefit Sharing – South African San Council Benefits: fixed value for 3 years; once-off for logo; % of net proceeds; 1% for use of logo 1 st Integrated Export and Bioprospecting permit USA: Zembrin 20 CASE STUDY: COMMERCIALISATION

21. Vervet monkey (Chlorocebus aethiops) 3 universities: Free State (RSA), California (USA), Wisconsin-Milwaukee (USA) Genetic polymorphism Map vervet monkey genome to establish it as non-human primate (NHP) model organism Natural host of simian immunodeficiency virus (SIV) 40- 60% infected Export of genetic material Transfer of genetic material to 3 rd parties Benefit Sharing: Species and genetic information  Conservation 21 CASE STUDY: RESEARCH

22. Pelargonium sidoides Used in medicines: Flugon, Linctagon, Umckaloabo Various traditional uses Benefit sharing agreements with Xhosa nation King Sandile and different Chiefs Difference in opinion on TK and BSA BSA public comment; Stakeholder engagement; Estimated date March 2011 Biodiversity Management Plan for species (BMP-s) 2011 22 CASE STUDY: TRADITIONAL KNOWLEDGE

23. 23 CASE STUDY: ROOIBOS TEA

24. 1. Ratification / Implementation2011 2. National ABS StrategyWhite Paper NBSAP NBF 3. National ABS Legislation2004 2008 4. Stakeholder identification & analysisIntergovernmental Bioprospecting Colloquium Provider / user interest groups 5. Establishing institutional arrangements, incl CAN Issuing authorities Expert Group 6. Dealing with TKDST IKS Policy 7. Transboundary issuesBilateral agreements (2014) 8. Valorization strategyDST Bioprospecting Platform (2011) 24 TO DO CHECKLIST

25. WHAT to do 1. Communication, Education and Public Awareness strategy 2. Stakeholder identification Access providers Traditional Knowledge holders 3. National legislation compliance Clear definitions Approval of agreements by issuing authority Assistance to communities 25 SUGGESTIONS FOR NATIONAL IMPLEMENTATION

26. THANK YOU Mrs Carina Malherbe Tel:+ 27 12 310 3799 CMalherbe@environment.gov.za Mrs Lactitia Tshitwamulomoni Tel: +27 12 310 3986 LMabadahane@environment.gov.za DEA website: www.environment.gov.za www.environment.gov.za Hotline Hotline +27 800 205 005 26